Hitachi C41V1 Manual de usuario

C41V1 Probe

INSTRUCTION MANUAL

Tokyo , Japan

Q1E-EP1432-7

Notes for operators and responsible maintenance personnel

★ Please read through this Instruction Manual carefully prior to use.

★ Keep this Instruction Manual together with the system with care to

make it available anytime.

0123

( 1 ) Q1E-EP1432

Manufacturer: Hitachi, Ltd.

2-16-1, Higashi-Ueno, Taito-ku, Tokyo,110-0015,

Japan

+81-3-6284-3668

http://www.hitachi.com/businesses/healthcare/

index.html

European

Representative: Hitachi Medical Systems GmbH

Otto-von-Guericke-Ring 3 D-65205 Wiesbaden,

Germany

EU Importer: Hitachi Medical Systems Europe Holding AG

Address: Sumpfstrasse 13 CH-6300 Zug, Switzerland

Local Distributor:

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About this manual

This instruction manual contains safety precautions, the inspection,

the operation procedure and the reprocessing procedure of C41V1 Probe.

Please read this manual thoroughly to ensure the safety operation.

If you have any questions concerning the operation of the probe, please

contact a service support.

The following conventions are used throughout the manual to denote

information of special emphasis.

WARNING: “Warning” indicates the presence of a hazard which may

result in severe personal injury, substantial property

damage, or death if the warning is ignored.

CAUTION: “Caution” indicates the presence of a hazard which will or

can cause minor personal injury or property damage if the

caution is ignored.

NOTICE: “Notice” indicates information of installation, operation,

or maintenance, which is important, but not hazard related.

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Graphical Symbols for Use in Labeling of Hitachi Ultrasound Probes

Some graphical symbols that are used in labeling of Hitachi Ultrasound Probes are

compliant with EN980:2008 standard. Refer to the following table about the meanings

of them.

Explanation of Symbol Symbol Descriptive Content

Manufacturer Company

Name and Address

Hitachi, Ltd.

2-16-1, Higashi-Ueno, Taito-ku,

Tokyo, 110-0015, Japan

+81-3-6284-3668

http://www.hitachi.com/businesses/

healthcare/index.html

Authorized

Representative

in The European

Community

Hitachi Medical Systems GmbH

Otto-von-Guericke-Ring 3 D-65205

Wiesbaden, Germany

Keep away

from Sunlight

Store the probe in a cool place and keep

away from high temperature, high

humidity, or direct sunlight.

Contains or presence of

natural rubber latex

Contains or presence of natural rubber

latex

Do not re-sterilize

Do not reuse

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Definition of symbol

The following symbol is also used for HITACHI Ultrasound Probes.

Location Symbol Definition

Probe connector

This instrument complies with

Directive 93/42/EEC relating to

Medical Device and Directive

2011/65/EU relating to RoHS

Probe connector IPX7 IPX7 mark

See section 1.6.

Probe connector Type BF APPLIED PART

Probe connector General warning sign

Probe connector Warning; dangerous voltage

Probe connector Caution; Biohazard

Probe connector

Follow the instruction manual to

operate this instrument. If not

avoided, may result in injury, property

damage, or the equipment trouble.

Probe connector

STERRAD sterilization compatibility

mark

Probe connector Do not waste the instrument as general

waste. Comply with a local regulation.

Probe connector Rx Only

By prescription only. U.S. Federal Law

restricts this device to sale on order

of a physician only.

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CONTENTS

Page

1. Introduction ................................................. 1

1.1 Features ......................................................... 1

1.2 Principles of operation .......................................... 1

1.3 Intended Use ..................................................... 2

1.4 Components ....................................................... 2

1.5 Accessories (Option) ............................................. 3

1.6 Construction ..................................................... 4

2. Inspection before Use ........................................ 5

2.1 Inspection for Appropriate Connection ............................ 5

2.2 Inspection for Material Surface .................................. 5

3. Operation Procedure .......................................... 6

3.1 Connection and Settings .......................................... 6

3.2 How to attach the Sterile Puncture Adapter (EZU-PA7V) ............ 8

3.3 Display of Needle Guide Line ..................................... 9

4. Option of C41V1 Probe ....................................... 11

4.1 Magnetic sensor ................................................. 11

5. Cleaning, Disinfection and Sterilization .................... 13

5.1 Point of use (Pre-cleaning) ..................................... 16

5.2 Containment and transportation .................................. 17

5.3 Manual Cleaning and disinfection ................................ 17

5.4 Drying .......................................................... 21

5.5 Inspection ...................................................... 21

5.6 Packaging ....................................................... 22

5.7 Sterilization ................................................... 23

5.8 Storage ......................................................... 25

6. Maintenance and Safety Inspection ........................... 26

6.1 Daily Inspection ................................................ 26

6.2 Store ........................................................... 26

7. Safety Precautions .......................................... 27

8. Specifications .............................................. 29

8.1 Probe ........................................................... 29

8.2 Sterile Puncture Adapter EZU-PA7V ............................... 30

8.3 Suppliers List .................................................. 31

9. Disposal of the probe ....................................... 31

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1. Introduction

1.1 Features

C41V1 Probe is a Convex Array Probe.

The acoustic output of this probe when connected to ultrasound

diagnostic scanner was measured according to the IEC60601-2-37

standard. The table of measured acoustic output data is contained

in the operational manual of each ultrasound diagnostic scanner.

This probe is categorized in class IIa according to Directive

93/42/EEC.

According to IEC60601-1 the probe is classified as type BF.

1.2 Principles of operation

This probe and the ultrasound diagnostic scanner enable image

diagnosis using ultrasonic waves. This system operates under the

principles described below.

1) When an electric pulse signal is applied from the transmitter

to the transducer of the probe, the transducer converts electric

signals into mechanical vibration energy for emitting

pulse-shaped ultrasonic waves into the body part, liquid or

other medium contacting the transducer.

2) The emitted ultrasonic waves are reflected by boundaries with

different acoustic characteristics (acoustic impedance) within

the body.

3) The transducer is also used to receive reflected ultrasonic

waves. The transducer vibrates mechanically due to the received

ultrasonic waves and converts mechanical vibrations into

electric energy. Electric signals are converted to shades of

brightness by brightness modulation to obtain an image.

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1.3 Intended Use

C41V1 Probe is designed for observation and diagnosis of the

following regions mainly by connecting with the HITACHI ultrasound

diagnostic scanner.

General OB/GYN organs

Biopsy (with a Sterile Puncture Adapter)

Transvaginal/Transrectal

Never use the probe for following regions.

1) The heart (Do not contact directly)

2) The eyeball

1.4 Components

Components of C41V1 Probe are as follows:

1) Probe ............................... 1 piece

2) Instruction Manual .................. 1 copy

The probe is not sterilized when delivered. Prior to use, be sure

to clean, disinfect and sterilize it.

WARNING

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CAUTION

1.5 Accessories (Option)

1.5.1 Sterile Puncture Adapter EZU-PA7V (Disposable)

EZU-PA7V is the attachment for ultrasound guided transvaginal

or transrectal biopsy and aspiration of organs, cyst and tumor.

The size of needles available is 16 to 19G. Biopsy application

requires special care. 24 pieces of Sterile Puncture Adapter

EZU-PA7V are packaged in one set as follows:

Component Model Note

Sterile Puncture Adapter EZU-PA7V 24 pcs

NOTE: If you need Sterile Puncture Adapters, please contact a service

support.

A well-trained physician only should perform a biopsy.

1.5.2 Probe cover for Single Use (Disposable)

To protect the probe against contamination, using probe cover

is recommended. If using probe cover, lubrication free or dry

type probe cover is recommended.

Lubrication may cause a deterioration of the probe surface.

Use of non-allergic probe cover is strongly recommended to

avoid allergic reactions due to latex rubber.

Discard the used probe cover carefully.

1.5.3 Magnetic Sensor Attachment

Magnetic Sensor Attachment is needed for Real-time Virtual

Sonography (RVS). It is used to fix the magnetic sensor to the

probe.

The Magnetic Sensor Attachment is not sterilized when delivered from

the factory. Prior to use, be sure to clean, disinfect and sterilize

it.

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1.6 Construction

The external view of C41V1 Probe is shown in Fig.1.

Immersible part: This part can be immersed in disinfectant solution

and also can be cleaned by water.

Un-immersible part: This part should not be immersed in disinfectant

solution and also can not be cleaned by water.

Fig.1

xternal view

able

Connector

mmer

ible

art

Immersible part (IP

)

Applied part

Magnetic sensor attachment (Option)

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